Actively Recruiting
Consolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007)
Led by Sun Yat-sen University · Updated on 2024-03-12
140
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
N
Nanfang Hospital, Southern Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Although definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable locally advanced esophageal cancer, elderly patients tolerate intravenous concurrent CRT less well with age and comorbidities. Previous trials have demonstrated that CRT with oral S-1 was tolerable and provided significant survival benefits over radiotherapy alone in elderly patients with esophageal squamous cell carcinoma (ESCC). However, as high as 54% of patients with elderly ESCC experienced locoregional or distant recurrence after CRT. Therefore, a more effective regimen for older patients is needed. Immune checkpoint inhibitors targeting PD-1/PD-L1 have shown substantial clinical benefits in advanced esophageal cancer. Recently, the combination of immunotherapy with CRT has emerged as a promising strategy to improve clinical outcomes in locally advanced esophageal cancer. The aim of this study was to evaluate the efficacy and safety of toripalimab (an anti-PD-1 antibody) after concurrent CRT in elderly patients with locally advanced ESCC.
CONDITIONS
Official Title
Consolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed squamous cell carcinoma of the esophagus
- Locally advanced disease without hematogenous metastasis according to UICC TNM version 8
- Not suitable for surgery due to medical reasons or patient choice
- Age between 70 and 85 years at diagnosis
- No prior cancer therapy
- Estimated life expectancy greater than 6 months
- Eastern Cooperative Oncology Group performance status of 2 or less
- No history of other simultaneous or previous cancers
- Adequate organ function including specific blood counts and liver and kidney tests
- Ability to understand the study and sign informed consent
You will not qualify if you...
- Previous treatment with anti-tumor therapy including chemotherapy, radiotherapy, surgery, or immunotherapy
- Presence of hematogenous metastasis or esophageal fistula at diagnosis
- Known allergy or hypersensitivity to monoclonal antibodies, cadonilimab ingredients, paclitaxel, or cisplatin
- Existing bleeding disorders
- Inability to provide informed consent due to psychological, social, or familial factors
- Peripheral neuropathy grade 2 or higher
- History of other malignancies except non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer
- Diabetes lasting more than 10 years with poor blood sugar control
- Severe cardiac, lung, liver, kidney dysfunction, hematopoietic disease, or cachexia preventing chemoradiotherapy tolerance
- Active or history of autoimmune diseases or immunodeficiency including HIV infection
- History of interstitial lung disease or non-infectious pneumonia
- Recent active pulmonary tuberculosis infection without formal treatment
- Active hepatitis B or C infection as defined by laboratory markers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mian Xi
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
M
Mian Xi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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